Severe OSA Study (SOS)

April 16, 2024 updated by: ProSomnus Sleep Technologies

A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea

This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea (OSA). Study participants will receive a custom ProSomnus EVO Sleep and Snore device and then be tested using a Type II home sleep apnea test (HSAT) to determine if they have achieved apnea-hypopnea index (AHI) < 15 h-1 with the device in place. Home sleep apnea testing will be conducted at predetermined timepoints rather than based on subjective measures such as symptom alleviation. After completing a set device advancement and testing protocol, study participants will complete a final HSAT six months after therapy initiation. This value will be used to determine the therapeutic success rate of the appliance. Safety evaluations will be conducted at each study visit that takes place after therapy initiation. These evaluations, along with dental examinations and adverse event reports, will be used to determine if the safety endpoint is met. Participants will continue to be followed for an additional six months after collection of data for the primary endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford Sleep Medicine Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Fayetteville, New York, United States, 13066
        • Advanced ENT Physicians and Surgeons of CNY
      • New York, New York, United States, 10010
        • Mount Sinai Integrative Sleep Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, of any race, aged 18-80 years (inclusive)

  4. Diagnosed with uncomplicated severe OSA (i.e., AHI > 30 h-1); where uncomplicated is defined by the absence of:

    1. Conditions that place the patient at increased risk of non-obstructive sleep-disordered breathing (e.g., central sleep apnea, hypoventilation, and sleep-related hypoxemia). Examples of such conditions include significant cardiopulmonary disease, potential respiratory muscles weakness due to neuromuscular conditions, history of stroke, and chronic opiate medication use.
    2. Concern for significant non-respiratory sleep disorder(s) that require evaluation (e.g., disorders of central hypersomnolence, parasomnias, sleep-related movement disorders) or interfere with accuracy of HSAT (e.g., severe insomnia).
    3. Environmental or personal factors that preclude the adequate acquisition and interpretation of data from HSAT.
  5. Body mass index (BMI) < 40 kg/m2
  6. Neck circumference < 50 cm
  7. Absence of severe oxyhemoglobin desaturation during sleep, indicated by mean nocturnal SpO2 > 87%
  8. Mandibular range of motion > 5 mm in protrusive direction
  9. Adequate dentition, as determined by the site dentist

Exclusion Criteria:

  1. Inability to breathe through the nose comfortably
  2. Presence of > 25% CSA
  3. Presence of positional obstructive sleep apnea per Cartwright's definition32
  4. History of surgery intended to alter anatomy for the correction of OSA, such as uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), or tongue/hyoid suspension. History of surgery intended to restore normal anatomy, such as tonsillectomy, adenoidectomy, septoplasty, or polypectomy, is permitted
  5. Presence of hypoglossal nerve stimulation device
  6. Use of CPAP or OAT within the two weeks prior to the screening HSAT
  7. History of OAT that has been demonstrated to provide effective therapy within the two years prior to the screening HSAT
  8. Anticipated change in medical therapy during the study protocol that could alter OSA severity (e.g., weight loss surgeries; UPPP, MMA, tongue/hyoid suspension)
  9. Loose teeth or advanced periodontal disease
  10. History of temporomandibular joint disorder
  11. Resistant hypertension, defined as inadequately controlled blood pressure despite therapy with ≥ 3 oral hypertensive agents
  12. Presence of congestive heart failure, recurrent atrial fibrillation, or coronary artery disease
  13. Presence of neuromuscular diseases, hypoventilation disorders, or cerebrovascular disease
  14. Presence of pulmonary disease resulting in significant desaturation, e.g., severe chronic obstructive pulmonary disease, interstitial lung disease (SaO2 nadir of 87%), or pulmonary hypertension
  15. History of cerebrovascular incident within the last 12 months
  16. Use of pacemaker or other life supporting device
  17. Anticipated change in body weight > 5% during the study period
  18. Participation in other studies that could interfere with the study protocol
  19. Pregnancy or lactation
  20. In the opinion of the investigator, unsuitable for inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EVO Sleep and Snore Device
Participants will be provided with a custom EVO Sleep and Snore Device
Device: ProSomnus® EVO Sleep and Snore Device
The ProSomnus® EVO Sleep and Snore Device is an intraoral device for snoring and obstructive sleep apnea. It works by repositioning the mandible during sleep, thereby improving the flow of air through the patient's pharyngeal space. The ProSomnus® EVO Sleep consists of maxillary and mandibular device arches that are CAD/CAM designed with twin-mated posts and digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy (apnea-hypopnea index)
Time Frame: 6 months
The AHI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve an AHI < 15 h-1 with the EVO Sleep and Snore Device 6 months after initiation of the therapy.
6 months
Efficacy (oxygen desaturation index)
Time Frame: 6 months
The ODI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve decrease in ODI from baseline of 25% or more with the EVO Sleep and Snore Device 6 months after initiation of the therapy.
6 months
Evaluation of safety (adverse events, dental examinations, safety examinations)
Time Frame: 6 months
The primary safety endpoint is to demonstrate an acceptable safety profile of the EVO Sleep and Snore Device, determined through assessment of all reported adverse events, dental examinations, and safety evaluations. There will be no formal statistical analysis.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: 6 months
The secondary endpoint is to demonstrate that the minimum clinically important difference (MCID) of -2 on the Epworth Sleepiness Scale (ESS) is achieved in participants with moderate to excessive daytime sleepiness (defined as ESS > 12). The Epworth Sleepiness Scale is a scale that ranges from 0 (no daytime sleepiness) to 18 (excessive daytime sleepiness).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ProSomnus Sleep Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Erin Mosca, PhD, ProSomnus Sleep Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PST202101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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